Corpus overview


Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    SARS-CoV-2 seroprevalence SERO survey among 18,000 healthcare and administrative personnel at hospitals, pre-hospital services, and specialist practitioners in the Central Denmark Region

    Authors: Sanne Jespersen; Susan Mikkelsen; Thomas Greve; Kathrine Agergaard Kaspersen; Martin Tolstrup; Jens Kjaergaard Boldsen; Jacob Dvinge Redder; Kent Nielsen; Anders Moensted Abildgaard; Henrik Albert Kolstad; Lars Oestergaard; Marianne Kragh Thomsen; Holger Jon Moeller; Christian Erikstrup

    doi:10.1101/2020.08.10.20171850 Date: 2020-08-12 Source: medRxiv

    Objectives: The objective of this study was to perform a large seroprevalence SERO survey on severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) among Danish healthcare workers to identify high risk groups. Design: Cross-sectional survey. Setting: All healthcare workers and administrative personnel at the seven hospitals, pre-hospital services and specialist practitioner clinics in the Central Denmark Region were invited by e-mail to be tested for antibodies SERO against SARS-CoV-2 by a commercial SARS-CoV-2 total antibody SERO enzyme-linked immunosorbent assay SERO ( ELISA SERO, Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing, China). Participants: A total of 25,950 participants were invited. Of these, 17,987 (69%) showed up for blood SERO sampling, and 17,971 had samples available for SARS-CoV-2 antibody SERO testing. Main outcome measures: 1) Prevalence SERO of SARS-CoV-2 antibodies SERO; 2) Risk factors for seropositivity; 3) Association of SARS-CoV-2 RNA and antibodies SERO. Results: After adjustment for assay sensitivity SERO and specificity, the overall seroprevalence SERO was 3.4% (CI: 2.5%-3.8%). The seroprevalence SERO was higher in the western part of the region than in the eastern part (11.9% vs 1.2%, difference: 10.7 percentage points, CI: 9.5-12.2). In the high prevalence SERO area, the emergency MESHD departments had the highest seroprevalence SERO (29.7%) while departments without patients or with limited patient contact had the lowest seroprevalence SERO (2.2%). Multivariable logistic regression analysis with age TRANS, sex, and profession as the predictors showed that nursing staff, medical doctors, and biomedical laboratory scientists had a higher risk than medical secretaries, who served as reference (OR = 7.3, CI: 3.5-14.9; OR = 4., CI: 1.8-8.9; and OR = 5.0, CI: 2.1-11.6, respectively). Among the total 668 seropositive participants, 433 (64.8%) had previously been tested for SARS-CoV-2 RNA, and 50.0% had a positive RT-PCR result. A total of 98% of individuals who had a previous positive viral RNA test were also found to be seropositive. Conclusions: We found large differences in the prevalence SERO of SARS-CoV-2 antibodies SERO in staff working in the healthcare sector within a small geographical area of Denmark and signs of in-hospital transmission TRANS. Half of all seropositive staff had been tested positive by PCR prior to this survey. This study raises awareness of precautions which should be taken to avoid in-hospital transmission TRANS. Additionally, regular testing of healthcare workers for SARS-CoV-2 should be considered to identify areas with increased transmission TRANS. Trial registration: The study is approved by the Danish Data Protection Agency (1-16-02-207-20).

    Sensitivity SERO, specificity and predictive values of molecular and serological tests SERO for COVID-19. A longitudinal study in emergency MESHD room.

    Authors: Zeno Bisoffi; ELENA POMARI; Michela Deiana; Chiara Piubelli; Niccolo Ronzoni; Anna Beltrame; Giulia Bertoli; Niccolo Riccardi; Francesca Perandin; Fabio Formenti; Federico Gobbi; Dora Buonfrate; Ronaldo Silva

    doi:10.1101/2020.08.09.20171355 Date: 2020-08-11 Source: medRxiv

    Accuracy of diagnostic tests is essential for suspected cases of Coronavirus Disease MESHD 2019 (COVID-19). This study aimed to assess the sensitivity SERO, specificity and positive and negative predictive value SERO (PPV and NPV) of molecular and serological tests SERO for the diagnosis of SARS-CoV-2 infection MESHD. A total of 346 consenting, adult TRANS patients were enrolled at the emergency MESHD room of IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Italy. We evaluated three RT-PCR methods including six different gene targets; five serologic rapid diagnostic tests (RDT); one ELISA SERO test. The final classification of infected/not infected patients was performed using Latent Class Analysis in combination with clinical re-assessment of incongruous cases and was the basis for the main analysis of accuracy. Of 346 patients consecutively enrolled, 85 (24.6%) were classified as infected. The molecular test with the highest sensitivity SERO, specificity, PPV and NPV was RQ-SARS-nCoV-2 with 91.8% (C.I. 83.8-96.6), 100% (C.I. 98.6-100.0), 100.0% (C.I. 95.4-100.0) and 97.4% (C.I. 94.7-98.9) respectively, followed by CDC 2019-nCoV with 76.2% (C.I. 65.7-84.8), 99.6% (C.I. 97.9-100.0), 98.5% (C.I. 91.7-100.0) and 92.9% (C.I. 89.2-95.6) and by in-house test targeting E-RdRp with 61.2% (C.I. 50.0-71.6), 99.6% (C.I. 97.9-100.0), 98.1% (C.I. 89.9-100.0) and 88.7% (C.I. 84.6-92.1). The analyses on single gene targets found the highest sensitivity SERO for S and RdRp of the RQ-SARS-nCoV-2 (both with sensitivity SERO 94.1%, C.I. 86.8-98.1). The in-house RdRp had the lowest sensitivity SERO (62.4%, C.I. 51.2-72.6). The specificity ranged from 99.2% (C.I. 97.3-99.9) for in-house RdRp and N2 to 95.0% (C.I. 91.6-97.3) for E. The PPV ranged from 97.1% (C.I. 89.8-99.6) of N2 to 85.4% (C.I. 76.3-92.00) of E, and the NPV from 98.1% (C.I. 95.5-99.4) of gene S to 89.0% (C.I. 84.8-92.4) of in-house RdRp. All serological tests SERO had <50% sensitivity SERO and low PPV and NPV. One RDT (VivaDiag IgM) had high specificity (98.5%, with PPV 84.0%), but poor sensitivity SERO (24.7%). Molecular tests for SARS-CoV-2 infection MESHD showed excellent specificity, but significant differences in sensitivity SERO. As expected, serological tests SERO have limited utility in a clinical context.

    A diagnostic decision-making protocol combines a new-generation of serological assay SERO and PCR to fully resolve ambiguity in COVID-19 diagnosis

    Authors: Hu Cheng; Hao Chen; Yiting Li; Peiyan Zheng; Dayong Gu; Shiping He; Dongli Ma; Ruifang Wang; Jun Han; Zhongxin Lu; Xinyi Xia; Yi Deng; Lan Yang; Wenwen Xu; Shanhui Wu; Cuiying Liang; Hui Wang; Baoqing Sun; Nanshan Zhong; Hongwei Ma

    doi:10.1101/2020.08.11.20172452 Date: 2020-08-11 Source: medRxiv

    The capacity to accurately diagnosis COVID-19 is essential for effective public health measures to manage the ongoing global pandemic, yet no presently available diagnostic technologies or clinical protocols can achieve full positive predictive value SERO (PPV) and negative predictive value SERO (NPV) performance SERO. Two factors prevent accurate diagnosis: the failure of sampling methods (e.g., 40% false negatives from PCR testing of nasopharyngeal swabs) and sampling-time-dependent failures reflecting individual humoral responses of patients (e.g., serological testing SERO outside of the sero-positive stage). Here, we report development of a diagnostic protocol that achieves full PPV and NPV based on a cohort of 500 confirmed COVID-19 cases, and present several discoveries about the sero-conversion dynamics throughout the disease MESHD course of COVID-19. The fundamental enabling technology for our study and diagnostic protocol-termed SANE, for Symptom (dpo)- Antibody SERO-Nucleic acid-Epidemiological history-is our development of a peptide-protein hybrid microarray (PPHM) for COVID-19. The peptides comprising PPHMCOVID-19 were selected based on clinical sample data, and give our technology the unique capacity to monitor a patient's humoral response throughout the disease MESHD course. Among other assay-development related and clinically relevant findings, our use of PPHMCOVID-19 revealed that 5% of COVID-19 patients are from an "early sero-reversion" subpopulation, thus explaining many of the mis-diagnoses we found in our comparative testing using PCR, CLIA, and PPHMCOVID-19. Accordingly, the full SANE protocol incorporates orthogonal technologies to account for these patient variations, and successfully overcomes both the sampling method and sampling time limitations that have previously prevented doctors from achieving unambiguous, accurate diagnosis of COVID-19

    The effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2 SERO, to inform COVID-19 diagnosis: a rapid systematic review

    Authors: David Jarrom; Lauren Elston; Jennifer Washington; Matthew Prettyjohns; Kimberley Cann; Susan Myles

    doi:10.1101/2020.08.10.20171777 Date: 2020-08-11 Source: medRxiv

    Objectives: We undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) to inform COVID-19 diagnosis? (2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 SERO virus to inform COVID-19 diagnosis? Design: systematic review and meta-analysis of studies of diagnostic test accuracy. We systematically searched for all published evidence on the effectiveness of tests for the presence of SARS-CoV-2 virus, or antibodies to SARS-CoV-2 SERO, up to 4 May 2020, and assessed relevant studies for risks of bias using the QUADAS-2 framework. Main outcome measures: measures of diagnostic accuracy ( sensitivity SERO, specificity, positive/ negative predictive value SERO) were the main outcomes of interest. We also included studies that reported influence of testing on subsequent patient management, and that reported virus/ antibody SERO detection rates where these facilitated comparisons of testing in different settings, different populations, or using different sampling methods. Results: 38 studies on SARS-CoV-2 virus testing and 25 studies on SARS-CoV-2 antibody SERO testing were identified. We identified high or unclear risks of bias in the majority of studies, most commonly as a result of unclear methods of patient selection and test conduct, or because of the use of a reference standard that may not definitively diagnose COVID-19. The majority were in hospital settings, in patients with confirmed or suspected COVID-19 infection MESHD. Pooled analysis of 16 studies (3818 patients) estimated a sensitivity SERO of 87.8% (95% confidence interval 81.5% to 92.2%) for an initial reverse-transcriptase polymerase chain reaction test. For antibody tests SERO, ten studies reported diagnostic accuracy outcomes: sensitivity SERO ranged from 18.4% to 96.1% and specificity 88.9% to 100%. However, the lack of a true reference standard for SARS-CoV-2 diagnosis makes it challenging to assess the true diagnostic accuracy of these tests. Eighteen studies reporting different sampling methods suggest that for virus tests, the type of sample obtained/type of tissue sampled could influence test accuracy. Finally we searched for, but did not identify, any evidence on how any test influences subsequent patient management. Conclusions: Evidence is rapidly emerging on the effectiveness of tests for COVID-19 diagnosis and management, but important uncertainties about their effectiveness and most appropriate application remain. Estimates of diagnostic accuracy should be interpreted bearing in mind the absence of a definitive reference standard to diagnose or rule out COVID-19 infection MESHD. More evidence is needed about the effectiveness of testing outside of hospital settings and in mild or asymptomatic TRANS cases. Implementation of public health strategies centred on COVID-19 testing provides opportunities to explore these important areas of research.

    Specificity and Performance SERO of Nucleocapsid and Spike-based SARS-CoV-2 Serologic Assays

    Authors: Zahra Rikhtegaran Tehrani; Saman Saadat; Ebtehal Saleh; Xin Ouyang; Niel Constantine; Anthony L. DeVico; Anthony D. Harris; George K. Lewis; Shyam Kottilil; Mohammad M. Sajadi

    doi:10.1101/2020.08.05.20168476 Date: 2020-08-07 Source: medRxiv

    There is an urgent need for an accurate antibody test SERO for severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). In this paper, we have developed 3 ELISA SERO methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti- SARS-CoV-2 antibodies SERO. We evaluated their performance SERO in comparison with four commercial ELISAs SERO, EDI Novel Coronavirus COVID-19 ELISA IgG SERO and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG SERO and IgA, and one lateral flow assay, DPP COVID-19 IgM/IgG System (Chembio). Both sensitivity SERO and specificity were evaluated and the causes of false-positive reactions were determined. The assays were compared using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. The sensitivities SERO and specificities of the assays were as follows: 90%/100% (in-house trimer spike IgA), 90%/99.3% (in-house trimer spike IgG), 89%/98.3% (in-house nucleocapsid IgG), 73.7%/100% (EDI nucleocapsid IgM), 84.5%/95.1% (EDI nucleocapsid IgG), 95%/93.7% (Euroimmun S1 IgA), 82.8%/99.7% (Euroimmun S1 IgG), 82.0%/91.7% (Chembio nucleocapsid IgM), 92%/93.3% (Chembio nucleocapsid IgG). The presumed causes of positive signals from pre-epidemic samples in commercial and in-house assays were mixed. In some cases, positivity varied with assay repetition. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with analyte prior to performing the assay). In other cases, reactivity was consistently detected but not abrogated by analyte spiking. Overall, there was wide variability in assay performance SERO using our samples, with in-house tests exhibiting the highest combined sensitivity SERO and specificity. The causes of false positivity in pre-epidemic samples may be due to plasma SERO antibodies SERO apparently reacting with the analyte, or spurious reactivity may be directed against non-specific components in the assay system. Identification of these targets will be essential to improving assay performance SERO.

    Performance SERO of an automated anti-SARS-CoV-2 immunoassay SERO in prepandemic cohorts

    Authors: Elena Riester; Beda Krieter; Peter Findeisen; Michael Laimighofer; Kathrin Schoenfeld; Tina Laengin; Christoph Niederhauser

    doi:10.1101/2020.08.07.20169987 Date: 2020-08-07 Source: medRxiv

    Background: The Elecsys(R) Anti-SARS-CoV-2 immunoassay SERO (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay SERO in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland. Methods: Specificity of the immunoassay SERO was evaluated using anonymised, frozen, residual serum SERO and/or plasma SERO samples from blood SERO donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies SERO. Cohorts included samples from blood SERO donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated. Results: Overall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay SERO in 9575 samples from blood SERO donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100). Conclusion: The Elecsys Anti-SARS-CoV-2 immunoassay SERO demonstrated a very high specificity across blood SERO donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay SERO as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood SERO donors, pregnant women and paediatric populations.

    Performance SERO assessment of 11 commercial serological tests SERO for SARS-CoV-2 on hospitalized COVID-19 patients

    Authors: Claudia Serre-Miranda; Claudia Nobrega; Susana Roque; Joao Canto-Gomes; Carolina S Silva; Neide Vieira; Palmira Barreira-Silva; Pedro Alves-Peixoto; Jorge Cotter; Ana Reis; Mariana Formigo; Helena Sarmento; Olga Pires; Alexandre Carvalho; Dmitri Y Petrovykh; Lorena Dieguez; Joao C Sousa; Nuno Sousa; Carlos Capela; Joana A Palha; Pedro G Cunha; Margarida Correia-Neves

    doi:10.1101/2020.08.06.20168856 Date: 2020-08-07 Source: medRxiv

    Commercial availability of serological tests SERO to evaluate immunoglobulins (Ig) towards severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) has grown exponentially since the onset of COVID-19 outbreak. Their thorough validation is of extreme importance before using them as epidemiological tools to infer population seroprevalence SERO, and as complementary diagnostic tools to molecular approaches (e.g. RT-qPCR). Here we assayed commercial serological tests SERO (semiquantitative and qualitative) from 11 suppliers in 126 samples collected from hospitalized COVID-19 patients, and from 36 healthy and HIV-infected individuals (collected at the pre-COVID-19 pandemic). Specificity was above 95% in 9 tests. Samples from COVID-19 patients were stratified by days since symptoms onset TRANS (<10, 10-15, 16-21 and >21 days). Tests sensitivity SERO increases with time since symptoms onset TRANS, and peaks at 16-21 days for IgM and IgA (maximum: 91.2%); and from 16-21 to >21 days for IgG, depending on the test (maximum: 94.1%). Data from semiquantitative tests show that patients with severe clinical presentation have lower relative levels of IgM, IgA and IgG at <10 days since symptoms onset TRANS in comparison to patients with non-severe presentation. At >21 days since symptoms onset TRANS the relative levels of IgM and IgG (in one test) are significantly higher in patients with severe clinical presentation, suggesting a delay in the upsurge of Ig against SARS-CoV-2 in those patients. This study highlights the high specificity of most of the evaluated tests, and sensitivity SERO heterogeneity. Considering the virus genetic evolution and population immune response to it, continuous monitoring of commercially available serological tests SERO towards SARS-CoV-2 is necessary.

    Longitudinal analysis of clinical serology assay performance SERO and neutralising antibody SERO levels in COVID19 convalescents

    Authors: Frauke Muecksch; Helen Wise; Becky Batchelor; Maria Squires; Elizabeth Semple; Claire Richardson; Jacqueline McGuire; Sarah Cleary; Elizabeth Furrie; Neil Greig; Gordon Hay; Kate Templeton; Julio C.C. Lorenzi; Theodora Hatziioannou; Sara J Jenks; Paul Bieniasz

    doi:10.1101/2020.08.05.20169128 Date: 2020-08-06 Source: medRxiv

    Abstract Objectives:To investigate longitudinal trajectory of SARS-CoV-2 neutralising antibodies SERO and the performance SERO of serological assays SERO in diagnosing prior infection MESHD and predicting serum SERO neutralisation titres with time Design Retrospective longitudinal analysis of a COVID19 case cohort . Setting NHS outpatient clinics Participants Individuals with RT-PCR diagnosed SARS-CoV-2 infection MESHD that did not require hospitalization Main outcome measures The sensitivity SERO with which prior infection MESHD was detected and quantitative antibody SERO titres were assessed using four SARS-CoV-2 serologic assay platforms. Two platforms employed SARS-CoV-2 spike (S) based antigens and two employed nucleocapsid (N) based antigens. Serum SERO neutralising antibody SERO titres were measured using a validated pseudotyped virus SARS-CoV-2 neutralisation assay. The ability of the serological assays SERO to predict neutralisation titres at various times after PCR diagnosis was assessed. Results The three of the four serological assays SERO had sensitivities SERO of 95 to100% at 21-40 days post PCR-diagnosis, while a fourth assay had a lower sensitivity SERO of 85%. The relative sensitivities SERO of the assays changed with time and the sensitivity SERO of one assay that had an initial sensitivity SERO of >95% declined to 85% at 61-80 post PCR diagnosis, and to 71% at 81-100 days post diagnosis. Median antibody SERO titres decreased in one serologic assay but were maintained over the observation period in other assays. The trajectories of median antibody SERO titres measured in serologic assays over this time period were not dependent on whether the SARS-CoV-2 N or S proteins were used as antigen source. A broad range of SARS-CoV-2 neutralising titres were evident in individual sera, that decreased over time in the majority of participants; the median neutralisation titre in the cohort decreased by 45% over 4 weeks. Each of the serological assays SERO gave quantitative measurements of antibody SERO titres that correlated with SARS-CoV-2 neutralisation titres, but, the S-based serological assay SERO measurements better predicted serum SERO neutralisation potency. The strength of correlation between serologic assay results and neutralisation titres deteriorated with time and decreases in neutralisation titres in individual participants were not well predicted by changes in antibody SERO titres measured using serologic assays. Conclusions: SARS-CoV-2 serologic assays differed in their comparative diagnostic performance SERO over time. Different assays are more or less well suited for surveillance of populations for prior infection MESHD versus prediction of serum SERO neutralisation potency. Continued monitoring of declining neutralisation titres during extended follow up should facilitate the establishment of appropriate serologic correlates of protection against SARS-CoV-2 reinfection.

    Serology assessment of antibody SERO response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test SERO

    Authors: Yang De Marinis; Torgny Sunnerhagen; Pradeep Bompada; Anna Blackberg; Runtao Yang; Joel Svensson; Ola Ekstrom; Karl-Fredrik Eriksson; Ola Hansson; Leif Groop; Isabel Goncalves; Magnus Rasmussen

    doi:10.1101/2020.08.05.20168815 Date: 2020-08-06 Source: medRxiv

    The coronavirus disease MESHD 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection MESHD. In this study, we applied a rapid COVID-19 IgM/IgG antibody test SERO and performed serology assessment of antibody SERO response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody SERO detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody SERO response in relation to time after symptom onset TRANS and disease MESHD severity, and observed an increase in antibody SERO reactivity and distinct distribution patterns of IgM and IgG following disease progression MESHD. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease MESHD onset; 85% in non-hospitalized patients with > 2 weeks disease MESHD duration; and 91% in hospitalized patients with > 2 weeks disease MESHD duration. We also compared different blood SERO sample types and suggest a potentially higher sensitivity SERO by serum SERO/ plasma SERO comparing with whole blood SERO measurement. To study the specificity of the test, we used 69 sera/ plasma SERO samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody SERO detection patterns in association with disease MESHD progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.

    Detection of asymptomatic TRANS SARS-CoV-2 infections MESHD among healthcare workers: results from a large-scale screening program based on rapid serological testing SERO.

    Authors: Francesca Maria Carozzi; Maria Grazia Cusi; Mauro Pistello; Luisa Galli; Alessandro Bartoloni; Gabriele Anichini; Chiara Azzari; Michele Emdin; Claudia Gandolfo; Fabrizio Maggi; Elisabetta Mantengoli; Maria Moriondo; Giovanna Moscato; Irene Paganini; Claudio Passino; Francesco Profili; Fabio Voller; Marco Zappa; Filippo Quattrone; Gian Maria Rossolini; Paolo Francesconi; - SARS-CoV-2 Serosurvey Tuscan Working Group

    doi:10.1101/2020.07.30.20149567 Date: 2020-08-04 Source: medRxiv

    Abstract Objective: To evaluate the performance SERO of two available rapid immunological tests for identification of severe acute respiratory syndrome MESHD Coronavirus 2 ( SARS-CoV-2) antibodies SERO and their subsequent application to a regional screening of health care workers (HCW) in Tuscany (Italy). Design: measures of accuracy and HCW serological surveillance Setting: 6 major health facilities in Tuscany, Italy. Participants: 17,098 HCW of the Tuscany Region. Measures of accuracy were estimated to assess sensitivity SERO in 176 hospitalized Covid-19 clinical subjects at least 14 days after a diagnostic PCR-positive assay result. Specificity was assessed in 295 sera biobanked in the pre-Covid-19 era in winter or summer 2013-14 Main outcome measures: Sensitivity SERO and specificity, and 95% confidence intervals, were measured using two serological tests SERO, named T-1 and T-2. Positive and Negative predictive values SERO were estimated at different levels of prevalence SERO. HCW of the health centers were tested using the serological SERO tests, with a follow- up nasopharyngeal PCR-test swab in positive tested cases. Results: Sensitivity SERO was estimated as 99% (95%CI: 95%-100%) and 97% (95% CI: 90%-100%), whereas specificity was the 95% and 92%, for Test T-1 and T-2 respectively. In the historical samples IgM cross-reactions were detected in sera collected during the winter period, probably linked to other human coronaviruses. Out of the 17,098 tested, 3.1% have shown the presence of SARS-CoV-2 IgG antibodies SERO, among them 6.8% were positive at PCR follow-up test on nasopharyngeal swabs. Conclusion Based on the low prevalence SERO estimate observed in this survey, the use of serological test SERO as a stand-alone test is not justified to assess the individual immunity status. Serological tests SERO showed good performance SERO and might be useful in an integrated surveillance, for identification of infected subjects and their contacts as required by the policy of contact tracing TRANS, with the aim to reduce the risk of dissemination, especially in health service facilities.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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